Cleared Traditional

K041272 - DYRACT CEM PLUS CEMENT

K041272 is the FDA 510(k) clearance for DYRACT CEM PLUS CEMENT by Dentsply Intl.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K041272 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
159d
Days
Class 2
Risk

K041272 is an FDA 510(k) clearance for the DYRACT CEM PLUS CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on October 18, 2004 after a review of 159 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Dentsply Intl. devices

Submission Details

510(k) Number K041272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2004
Decision Date October 18, 2004
Days to Decision 159 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 127d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EMA Cement, Dental

All 291
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K041272.
SYSTEMP.LINK
K042846 · Ivoclar Vivadent, Inc. · Dec 2004
SYSTEMP.CEM
K042847 · Ivoclar Vivadent, Inc. · Dec 2004
IONOFIL PLUS AC
K042669 · Voco GmbH · Oct 2004
RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT
K042215 · Premier Dental Products Co. · Sep 2004
MAXCEM
K041474 · Sybron Dental Specialties, Inc. · Jul 2004
CALIBRA CEMENT
K040906 · Dentsply Intl. · Jun 2004